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FDA 510(k)

KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)

K-Number: K964401 · 1997-02-06

ApplicantLudlow Technical Products
Decision Date1997-02-06
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) is the device name listed in this FDA 510(k) record. The listed applicant is Ludlow Technical Products. It received FDA 510(k) clearance on 1997-02-06 under 510(k) number K964401. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)?

KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is Ludlow Technical Products. The 510(k) number is K964401.

When did KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) receive FDA 510(k) clearance?

KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) received FDA 510(k) clearance on 1997-02-06, under 510(k) number K964401.

Who is the listed applicant for KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)?

The FDA 510(k) record lists Ludlow Technical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)?

The FDA product code for KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) is FMT.

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Other records listing Ludlow Technical Products as applicant

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K991235SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)K973110LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORDK972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESK931903SURELOCK(TM) SNAPLESS MONITORING ELECTRODE

Related Devices (Code: FMT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.K201628Panda iRes Warmer, Giraffe WarmerGE HealthcareK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal Industries, Inc.K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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